RetentionNCT05014308
Effect of Piezoelectric Alveolar Decortication on Post-Orthodontic Lower Incisors Stability: A Randomized Clinical Trial
A study testing Piezoelectric Alveolar Decortication, fibrotomy in people with Retention, run by King Abdulaziz University.
Trial summary
To assess the effect of piezocision on post-orthodontic lower anterior teeth stability as compared to fiberotomy and conventional Hawley retainers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Retention
- What is being tested?
- Piezoelectric Alveolar Decortication, fibrotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2016to 5 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals who had lower anterior irregularity (crowding, rotation, buccally or lingually displaced) will be selected.
- Good oral hygiene, healthy gingiva and no evidence of bone loss as seen on the radiograph.
- Healthy systemic conditions.
- Patients pass the growth spurt according to cervical vertebral maturation method as described by Baccetti et al.
- Availability of good quality records at pretreatment and post-treatment.
Who cannot join
- Patients that has any signs of active periodontal disease or evidence of bone loss on the radiograph.
- Patients with systemic disease such as osteoporosis and diabetes.
- Smoking patients.
- Study casts did not include all mandibular permanent incisors, canines, and first molars.
About this study
To assess the effect of piezocision on post-orthodontic lower anterior teeth stability as compared to fiberotomy and conventional Hawley retainers.
- Conditions
- Retention
- Being tested
- Piezoelectric Alveolar Decortication, fibrotomy
- Keywords
- Retention; Relapse; Fibrotomy; Piezocision;
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezoelectric Alveolar Decortication, fibrotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| piezocision group | Experimental | piezocision surgical procedure was done according to Dibart's et al, Receives: Procedure: Piezoelectric Alveolar Decortication, fibrotomy |
| fiberotomy group | Experimental | the fiberotomy procedure followed Edward's et al Receives: Procedure: Piezoelectric Alveolar Decortication, fibrotomy |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower incisors stability after 6 months
study models will be evaluated 6 months after debonding Incisor Irregularity Index of lower anterior teeth will be measured using a digital caliper
Measured: 6 months
lower incisors stability after 12 months
study models will be evaluated 12 months after debonding Incisor Irregularity Index of lower anterior teeth will be measured using a digital caliper
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start15 Mar 2016
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Fahmy Saqat, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014308
- Sponsor's protocol ID
- 16011965
- Status last verified
- Aug 2021
- First submitted
- 11 Apr 2017
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Piezoelectric Alveolar Decortication on Post-Orthodontic Lower Incisors Stability: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05014308
- Acronym / sponsor ID
- 16011965
- Conditions
- Retention
- Keywords
- Retention; Relapse; Fibrotomy; Piezocision;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of piezocision on post-orthodontic lower anterior teeth stability as compared to fiberotomy and conventional Hawley retainers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| piezocision group | Experimental | Procedure: Piezoelectric Alveolar Decortication, fibrotomypiezocision surgical procedure was done according to Dibart's et al, |
| fiberotomy group | Experimental | Procedure: Piezoelectric Alveolar Decortication, fibrotomythe fiberotomy procedure followed Edward's et al |
| control group | No intervention | –no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who had lower anterior irregularity (crowding, rotation, buccally or lingually displaced) will be selected.
- Good oral hygiene, healthy gingiva and no evidence of bone loss as seen on the radiograph.
- Healthy systemic conditions.
- Patients pass the growth spurt according to cervical vertebral maturation method as described by Baccetti et al.
- Availability of good quality records at pretreatment and post-treatment.
Key exclusion criteria (4 listed)
- Patients that has any signs of active periodontal disease or evidence of bone loss on the radiograph.
- Patients with systemic disease such as osteoporosis and diabetes.
- Smoking patients.
- Study casts did not include all mandibular permanent incisors, canines, and first molars.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piezoelectric Alveolar Decortication, fibrotomy | Procedure or surgery | fiberotomy group, piezocision group |
Primary outcome
lower incisors stability after 6 months
Time frame: 6 months
study models will be evaluated 6 months after debonding Incisor Irregularity Index of lower anterior teeth will be measured using a digital caliper
lower incisors stability after 12 months
Time frame: 12 months
study models will be evaluated 12 months after debonding Incisor Irregularity Index of lower anterior teeth will be measured using a digital caliper
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Piezoelectric Alveolar Decortication, fibrotomy in people with Retention, run by King Abdulaziz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower incisors stability after 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.